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the ANSM confirms a risk of rare thrombosis


The Medicines Agency (ANSM) confirmed on Friday the existence of a “rare” risk of atypical thrombosis associated with AstraZeneca’s Covid-19 vaccine, after the occurrence of new cases in France, including two deaths, all by emphasizing that the risk / benefit balance remained “favorable”. “Nine cases of thrombosis of the large veins, atypical by their location (mainly cerebral, but also digestive), which may be associated with thrombocytopenia – decrease in the number of platelets in the blood, Editor’s note – or coagulation disorders have been declared “, six more than the previous week, indicates the ANSM in its latest update on the surveillance of vaccines against Covid-19.

“Two deaths” reported

Among these cases, “two deaths” were reported between March 12 and 18, including that of a Nantes medical student who died on March 18 several days after being vaccinated, mentioned Monday evening by the ANSM in a press release and for which additional analyzes are in progress, as part of a judicial inquiry.

The very atypical nature of these thromboses, their similar clinical pictures and the homogeneous time to onset lead the monitoring committee to confirm the very rare occurrence of this thrombotic risk in people vaccinated with the AstraZeneca vaccine “, explains the health agency. .

These cases occurred “within a median of 8.5 days after vaccination in people with no particular history identified to date”, she adds, adding that seven patients were under 55 years old, and two, over 55 years.

The vaccine developed by the Swedish-British laboratory and the University of Oxford was suspended on March 15 by several European countries after reports of blood clots, sometimes fatal.

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France lifted the suspension on Friday, after an opinion from the European Medicines Agency (EMA) deeming it “safe and effective” and affirming that its benefit / risk balance in the face of the Covid-19 epidemic was positive. The Haute Autorité de santé, however, recommended that it be reserved for people aged 55 and over because until then cases of cerebral venous thrombosis had only been observed in children under 55 years of age.

5,700 side effects analyzed

The EMA concluded that the vaccine was not associated with an increased overall risk of blood clots but that a “possible link with two very rare forms of blood clots (disseminated intravascular coagulation (DIC) and cerebral venous sinus thrombosis ) associated with blood platelet deficiency (could) not be ruled out at this stage “. “A group of experts” from the EMA is studying “the mechanism of action, the possible underlying risk factors and any additional data to explain the events observed”, recalls the ANSM.

Out of 1.4 million AstraZeneca vaccines injected in France on March 18, around 5,700 adverse effects were analyzed by pharmacovigilance centers, the “vast majority” of “flu-like syndromes, often of high intensity” (fever, headaches, body aches).



Source site www.europe1.fr

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